Alere HomeLink scores FDA clearance for OTV use

Alere HomeLink

Alere Connect scored a 510(k) market clearance from the U.S. FDA for Alere HomeLink, which provides a gateway to Alere’s Connected Health platform, with integrated products and services for health management. The product has also received CE Mark certification, which allows it to be marketed within Europe as well as in the US.

This new product offering joins the company’s existing connected device technologies that are designed to empower patients to self-test at home and deliver data quickly to clinical systems accessed by their healthcare providers.

Alere HomeLink will be deployed in health management programs administered by Alere Health for patients managing chronic conditions, such as diabetes, hypertension, heart failure and chronic obstructive pulmonary disease (COPD), at home. The device can connect to multiple compatible monitoring devices with Bluetooth and Low-Energy Bluetooth for wireless integration. It can also use a wired USB connection if needed.

The Alere HomeLink has a 7-inch touchscreen that allows patients to submit responses to disease management questions along with their test measurements.

All of Alere Connect’s cellular communication hubs use the proprietary Alere CloudCare Platform to connect medical devices in the field to clinical backend systems. The Platform facilitates a flow of diagnostic data to Alere’s Health Information Exchange solution for integration across the continuum of care.